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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02834962
Other study ID # ACLMRI-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 13, 2016
Last updated July 14, 2016
Start date July 2016
Est. completion date August 2017

Study information

Verified date July 2016
Source Peking University Third Hospital
Contact Yu Jia-Kuo, MD
Phone 86-10-82267392
Email yujiakuo@126.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.


Description:

The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 50 Years
Eligibility Inclusion Criteria:

- ACL rupture patients aged between 10 to 50 years

Exclusion Criteria:

- combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)

- any injury or surgery to the contralateral knee

- any inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Rupture
  • Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
single bundle ACL reconstruction
anterior cruciate ligament reconstruction using single bundle technique
double bundle ACL reconstruction
anterior cruciate ligament reconstruction using double bundle technique

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary cross-sectional area of the reconstructed ACL 3-6 weeks No
Primary long to short axis ratio of the cross-sectional area of the reconstructed ACL 3-6 weeks No
Primary long axis of the cross-sectional area of the reconstructed ACL 3-6 weeks No
Primary short axis of the cross-sectional area of the reconstructed ACL 3-6 weeks No
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